Label: CHILDRENS ACETAMINOPHEN- acetaminophen suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 59999-001-04 - Packager: R3 Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 25, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL = 1 teaspoon)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash nausea, or vomiting consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
When using this product do not exceed recommended dose (see overdose warning)
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Directions
- do not give more than directed (see Liver and overdose warning)
- shake well before use
- this product does not contain directions or complete warnings for adult use
- use only with enclosed dosing cup
- repeat dose every 4 hours if needed
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
- find right dose on chart below. If possible, use weight to dose, otherwise; use age.
Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1 tsp or 5 mL 36-47 4-5 years 1 1/2 tsp or 7.5 mL 48-59 6-8 years 2 tsp or 10 mL 60-71 9-10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
CHILDRENS ACETAMINOPHEN
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59999-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CARRAGEENAN (UNII: 5C69YCD2YJ) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59999-001-04 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 09/23/2013 Labeler - R3 Pharmaceuticals, LLC (078888843)